DEPARTMENT OF HEALTH & HUMAN SERVICES
VIA EXPRESS MAIL
Mr. Kitti Nuvat, Owner
Green Giant Ltd., Part.
1735/129 Pinklao-Nakornchairsri Road,
Reference No.: 248495
Dear Mr. Nuvat:
The U.S. Food and Drug Administration (FDA) inspected your low-acid canned food and acidified foods facility located at 1735/129 Pinklao-Nakornchairsri Road, Bangbamru, Bangkoknoi, Thailand on June 9-10, 2011.
As a manufacturer of low-acid canned food products, you are required to comply with the U.S. Federal Food, Drug, and Cosmetic Act (the Act), and the federal regulations relating to the processing of low-acid canned food products. These regulations are described in Title 21, Code of Federal Regulations, Part 108, Emergency Permit Control (21 CFR 108), and Part 113, Low-Acid Canned Foods (21 CFR 113). Failure to comply with all of the mandatory requirements of 21 CFR 108.35 and 21 CFR Part 113 constitutes a basis for the immediate application of the emergency permit control provisions of Section 404 of the Act and particularly implementation of 21 CFR 108.35(k) for products offered for entry into the United States. In addition, such failure renders your low-acid canned food products adulterated within the meaning of Section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4). You can find the Act and the low-acid canned food regulations through links in FDA’s home page at http://www.fda.gov.
This inspection resulted in FDA’s issuance of an FDA-483, Inspectional Observations, at the conclusion of the inspection which listed the deviations found at your firm. Your firm has not responded to the FDA-483 to address the deviations. We note the following serious deviations from the low-acid canned food regulations:
- Your firm’s retort did not have an accurate temperature-recording device as required by 21 CFR 113.40(a)(2). Specifically, the temperature recording chart attached to the b(4) Steam Retort was not operational. All retorts are required to have an accurate temperature recording device in addition to the Mercury in Glass (MIG) thermometer (21 CFR 113.40). The firm did not have a functional temperature recording device attached to either one of their two retorts.
- Your firm failed to equip retorts with automatic steam controllers to maintain retort temperatures as required by 21 CFR 113.40(a)(4). Specifically, retort #2 was observed to be operating without an Automatic Steam Controller. The retort operator was manually adjusting the steam amount to maintain the proper temperature.
- Your firm failed to test your MIG thermometers against a known accurate standard thermometer yearly to ensure accuracy as required by 21 CFR 113.40(a)(1). Specifically the MIG thermometer was last calibrated in December 2009.
You should respond in writing within thirty (30) working days from your receipt of this letter. Your response should outline the specific things you are doing to further correct these violations. You should include in your response documentation that would assist us in evaluating your corrections. If you cannot complete all corrections within thirty (30) days you should explain the reason for your delay and state when you will correct any remaining violations.
The inspection also revealed serious violations of FDA’s Current Good manufacturing Practice in Manufacturing, Packing, or Holding Human Food (CGMP) regulation, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). These violations include: the failure to exclude pests from the processing area, the lack of effective hand cleaning stations, floors that are not in good repair and a lack of effective screening against pests.
This letter may not list all the violations at your facility. You are responsible for ensuring that you firm operates in compliance with the Act, the low-acid canned food regulations (21 CFR Parts 108 and 113), the Current Good Manufacturing Practice regulation (21 CFR Part 110), and other applicable regulations. You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.
Please send your reply to the U. S. Food and Drug Administration, Attention: Carol D’lima, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Manufacturing and Storage Adulteration Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding any issue in this letter, you may contact Ms. D’lima at (240) 402-2033 or via email at firstname.lastname@example.org.
Kathleen M. Lewis, J.D.
Division of Enforcement
Office of Compliance
Center for Food Safety
and Applied Nutrition